Cleared Traditional

K170551 - ImPACT Quick Test

K170551 is an FDA 510(k) clearance for ImPACT Quick Test, manufactured by Impact Applications, Inc.. The device is a Class 2 Neurology device with product code POM cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K170551 · Impact Applications, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
117d
Days
Class 2
Risk

K170551 is an FDA 510(k) clearance for the ImPACT Quick Test. Classified as Computerized Cognitive Assessment Aid For Concussion (product code POM), Class II - Special Controls.

Submitted by Impact Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 21, 2017 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1471 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impact Applications, Inc. devices

FDA 510(k) Submission Details - K170551

510(k) Number K170551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date June 21, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 149d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

POM Device Classification - Class 2, Special Controls

Product Code POM Computerized Cognitive Assessment Aid For Concussion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1471
Definition For Use As An Assessment Aid In The Management Of Concussion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02597504 Terminated Interventional Industry-sponsored

Development of a Neurocognitive Screening Test

1600
Patients (actual)
4
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Brain Concussion; Mild Cognitive Impairment
Study design Parallel
Eligibility All sexes · 6 Years+ · Healthy volunteers accepted
Sponsor ImPACT Applications, Inc. (industry)
Started 2015-10-01 → Primary completion 2019-10-01
Primary outcome
Reliability will be established through a test-retest to establish results should be stable over time
View full study on ClinicalTrials.gov

Regulatory Peers - POM Computerized Cognitive Assessment Aid For Concussion

All 7
Devices cleared under the same product code (POM) and FDA review panel - the closest regulatory comparables to K170551.
ANAM Test System
K201376 · Vista Lifesciences, Inc. · Mar 2021
ImPACT Version 4
K202485 · Impact Applications, Inc. · Dec 2020
ImPACT
K181223 · Impact Applications, Inc. · Oct 2018
ImPACT
K170209 · Impact Applications, Inc. · Feb 2017
ImPACT Computerized Neurocognitive Concussion Management Aid
DEN150037 · Impact Applications, Inc. · Aug 2016